Please do not apply for this role - ONLY FOR TESTING PURPOSE We Don’t Just Build The World, We Build Innovative Technology Too. Joining the Stanley Black & Decker team means working in an innovative, tech-driven and highly collaborative team environment supported by over 58,000 professionals in 60 countries across the globe. Here, you’ll get the unique chance to impact some of the world’s most iconic brands including STANLEY TOOLS, DEWALT, CRAFTSMAN, MAC TOOLS and Black + Decker. Your ideas and solutions have the potential to reach millions of customers as we work together to write the next chapter in our history. Come build with us and take your career to new heights. Who We Are We’re the World’s largest tool company. We’re industry visionaries. We’re solving problems and advancing the manufacturing trade through innovative technology and our Industry 4.0 Initiative. We are committed to ensuring our state-of-the-art “smart factory” products and services provide greater quality to our customers & greater environmental and social value to our planet. We are unique in that we have a rich and storied history dating back to 1843, but that hasn't stopped us from evolving into a vibrant, diverse, global growth company. Global Benefits & Perks You’ll be rewarded with a competitive salary plus receive entitlements and benefits unique to your country of hire. What You’ll Also Get Career Opportunity: Career paths aren’t linear here. Being part of our global company with 60+ brands gives you the chance to grow and develop your skills along multiple career paths. Learning & Development: Our lifelong learning philosophy means you’ll have access to a wealth of state-of-the-art learning resources, including our Lean Academy and online university (where you can get certificates and specializations from renowned colleges and universities). Diverse & Inclusive Culture: We pride ourselves on being an awesome place to work. We respect and embrace differences because that’s how the best work gets done. You’ll find we like to have fun here, too. Purpose-Driven Company: You’ll help us continue to make positive changes in the local communities where we work and live as well as in the broader world through volunteerism, giving back and sustainable business practices.

Please do not apply for this role - ONLY FOR TESTING PURPOSE We Don’t Just Build The World, We Build Innovative Technology Too. Joining the Stanley Black & Decker team means working in an innovative, tech-driven and highly collaborative team environment supported by over 58,000 professionals in 60 countries across the globe. Here, you’ll get the unique chance to impact some of the world’s most iconic brands including STANLEY TOOLS, DEWALT, CRAFTSMAN, MAC TOOLS and Black + Decker. Your ideas and solutions have the potential to reach millions of customers as we work together to write the next chapter in our history. Come build with us and take your career to new heights. Who We Are We’re the World’s largest tool company. We’re industry visionaries. We’re solving problems and advancing the manufacturing trade through innovative technology and our Industry 4.0 Initiative. We are committed to ensuring our state-of-the-art “smart factory” products and services provide greater quality to our customers & greater environmental and social value to our planet. We are unique in that we have a rich and storied history dating back to 1843, but that hasn't stopped us from evolving into a vibrant, diverse, global growth company. Global Benefits & Perks You’ll be rewarded with a competitive salary plus receive entitlements and benefits unique to your country of hire. What You’ll Also Get Career Opportunity: Career paths aren’t linear here. Being part of our global company with 60+ brands gives you the chance to grow and develop your skills along multiple career paths. Learning & Development: Our lifelong learning philosophy means you’ll have access to a wealth of state-of-the-art learning resources, including our Lean Academy and online university (where you can get certificates and specializations from renowned colleges and universities). Diverse & Inclusive Culture: We pride ourselves on being an awesome place to work. We respect and embrace differences because that’s how the best work gets done. You’ll find we like to have fun here, too. Purpose-Driven Company: You’ll help us continue to make positive changes in the local communities where we work and live as well as in the broader world through volunteerism, giving back and sustainable business practices.

We are seeking a senior QA specialist who will play a critical role in driving compliance and quality across the organization’s biometric services and computer systems. This role involves hands-on execution of QA activities, leadership in audits and risk management, and close collaboration with cross-functional teams such as data management, biostatistics, statistical programming, software development and validation, and IT and security.  The senior QA specialist will ensure that processes, computer systems, and deliverables adhere to GxP, ICH-GCP, 21 CFR Part 11, and other applicable regulations, as well as internal quality standards through proactive oversight, documentation review, system validation, and continuous process improvement.  Essential Functions and Responsibilities  1. Document & Process Auditing  - Conduct and/or host internal audits and vendor audits  - Review and audit Trial Master File (TMF) for completeness, accuracy, and compliance  - Track and report audit findings, deviations, and CAPAs (Corrective and Preventive Actions)  - Perform risk-based audit planning and inspection readiness assessments  2. SOPs, Policies and QMS Maintenance  - Review and assist in developing policies, SOPs, work practice documents, forms and other Quality Management System (QMS) documents  - Ensure alignment with the company’s Quality Policy and applicable external regulations  - Ensure controlled documents are reviewed periodically and in a timely manner  - Document and manage deviations, nonconformances, and CAPAs  - Maintain quality records and support archiving in accordance with regulatory timelines   3. Training Management  - Collaborate with functional managers to establish and periodically review training curricula, including study-specific training for internal teams  - Monitor overdue training, and follow up with individuals and their supervisors until completion  4. Computer System Validation Support  - Participate in validation planning and execution for internal and customer-facing systems  - Collaborate with software validation team and IT to review:  - Computer system validation plan (CVP)  - Functional/user requirements specifications and risk assessments  - Test scripts, validation protocols (IQ/OQ/PQ), and traceability matrices  - Test run reports and validations summary reports  - Review change requests, bug reports, and ensure re-validation as needed  - Ensure systems comply with 21 CFR Part 11 requirements, including audit trails, access control, and electronic signatures  5. Audit and Inspection Readiness  - Plan, execute, and document internal process audits, project/study audits, and vendor audits.  - Coordinate with IT and product teams to ensure systems and environments are audit-ready by confirming that the following activities are performed in accordance with SOPs:  - Systems are validated and reviewed in a timely manner  - Audit trails and system logs are monitored and reviewed  - Access reviews, system related exercises and tests, and security scans are performed periodically  - Coordinate with biometric teams to ensure services are performed in accordance with applicable regulations and EDETEK SOPs, including following QC processes, proper document versioning, review and approval, and appropriate documentation and sign-off for deviations  - Lead or assist in pre-inspection readiness for regulatory audits (e.g., FDA, EMA, MHRA).  - Track findings, respond to audit reports, manage CAPAs through resolution and effectiveness checks, and ensure timely completion with evidence retained for review  6. Cross-Functional Support  - Act as a QA liaison across departments, including Biometrics, Software Development, and IT/Security.  - Mentor junior QA team members by providing training and peer reviews.  - Represent QA in project meetings, product releases, and client quality discussions.  - Respond to client quality inquiries and due diligence questionnaires.  7. Continuous Improvement  - Lead or contribute to risk assessments for clinical projects, software systems, and vendor engagements.  - Identify quality gaps or inefficiencies and propose remediation or process improvement initiatives.  - Monitor and analyze quality metrics and trends (e.g., deviation rates, audit findings, CAPA effectiveness).  - Contribute to QMS improvement projects and ensure effective cross-functional adoption.

Job Opening: QA Specialist Location: Remote (Working US Hours - 9am-5pm EST) Type: Full-Time Salary: Paid in South African Rand (ZAR) Key Responsibilities - Conduct regular audits of clinical documentation, session notes, treatment plans, and assessments to ensure accuracy and compliance - Review submitted claims and supporting documentation for completeness and alignment with payer requirements - Identify errors, inconsistencies, or missing information and coordinate corrections with relevant team members - Ensure adherence to ABA best practices, company policies, and insurance guidelines - Monitor compliance with authorization requirements and service delivery standards - Collaborate with BCBAs, RBTs, and administrative staff to resolve documentation or billing discrepancies - Track and report on audit findings, trends, and areas for improvement - Develop and implement quality improvement initiatives and standard operating procedures (SOPs) - Provide feedback and training to staff on documentation quality and compliance standards - Stay up to date with changes in ABA regulations, payer requirements, and industry best practices